Carmat has announced the first implantation of its bioprosthetic artificial heart, Aeson, in the USA within the framework of an Early Feasibility Study (EFS).
The implant procedure was performed by a team led by Jacob N Schroder and Carmelo A Milano, surgeons at Duke University Hospital, Durham, USA. It is the first US hospital to implant Aeson within the framework of the EFS. Three additional US centres are currently screening patients for the study.
In accordance with the study protocol approved by the US Food and Drug Administration (FDA), 10 transplant-eligible patients are expected to be enrolled in this trial. The primary study endpoint is patient survival at 180 days post-implant or a successful cardiac transplantation within 180 days post-implant. It is a staged study with a progress report of the first three patients after 60 days, before the enrolment of the next seven patients.
Milano, the principal investigator of the study, stated: “We are pleased to be the first US centre to investigate a new therapeutic alternative for critically ill patients suffering from end-stage biventricular heart failure. This clinical study will help us determine whether the device’s properties—including haemocompatibility, pulsatility, autoregulation and silent operation—are beneficial to patients who currently have very few options.”
Stéphane Piat, chief executive officer of Carmat, added: “We are honoured that our device is implanted at Duke University Hospital, which is recognised throughout the USA for its quality of care and research. I would like to congratulate the teams at the hospital, as well as our technical and medical staff, on this exceptional milestone for both patients and our company. I am also very pleased that, despite the procedures hardened by the COVID-19 situation, three other centres are now fully trained and ready to join our first US clinical study that will be instrumental to our development in the world’s largest medical device market.”